Model Number N/A |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.(b)(6).
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Event Description
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It was reported that the device handpiece is losing power when pressed to skin.No adverse events were reported as a result of this malfunction.
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Event Description
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There is no additional information.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the unit was losing power when pressed against skin; the depth bar was loose and the width plates were worn and require replacement; however, the repair was not completed because the repair is pending customer approval.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Search Alerts/Recalls
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